Devices and Methods for End-To-End Anastomosis

This patent application claims priority to U.S. provisional Ser. No. 63/387,415, titled “DEVICES AND METHODS FOR END-TO-END ANASTOMOSIS,” and filed on Dec. 14, 2022, which is herein incorporated by reference in its entirety.

All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

The present invention relates to performing an end-to-end anastomosis system, particularly an anastomosis in a patient's colon, by minimally invasive surgery.

Colorectal cancer is the third most common cancer worldwide, with over 1.9 million new cases in 2020. Colorectal cancer is the third most commonly occurring cancer and the second most commonly occurring cancer in women globally. The global incidence of colorectal cancer is expected to increase by 60% to over 2.2 million new cases and 1.1 million annual deaths by the year 2030. The causes of such cancers are certain but are likely related to obesity, processed foods, smoking, and more sedentary lifestyles.

Treatments for colorectal cancer typically include resection of a diseased part of the patient's colon. Following such a resection, a surgical anastomosis is performed wherein the free ends of the intestine are reconnected. One of the most serious complications of anastomosis is anastomotic leakage which occurs in up to 20% of patients undergoing such a resection procedure. Leakage from the anastomosis site causes fecal material to enter the abdominal cavity and can lead to serious complications such as peritonitis, septic shock and can be life threatening. Such an anastomotic leakage is not always immediately detectable and can result in re-operations and extended times in hospitals.

In one embodiment, there is a method of providing end-to-end anastomosis in an intestine of a patient. One step in the method includes resecting a portion of the intestine leaving a first free end of the intestine and a second free end of the intestine. The intestine having a wall comprising a mucosa, a muscularis, and a serosa, where the muscularis and the serosa comprise an outward layer of the intestine. Next, there is a step of separating the mucosa from the outward layer at the first free end to provide an elongated free end of the mucosa at the first free end.

There is also a step of positioning the elongated free end of the mucosa in a lumen of the second free end. In another step, there is attaching the outward layer of the first free end to a wall of the second free end at an interface to provide an end-to-end anastomosis. In one aspect, the elongated free end of the mucosa overlaps the interface to prevent intestinal leakage at the interface.

In additional aspects, prior to attaching the outward layer of the first free end to the wall of the second free end, the outward layer of the first free end and the wall of the second free end are everted or folded outwardly. Optionally, prior to attaching the outward layer of the first free end to the wall of the second free end, the outward layer of the first free end and the wall of the second free end are folded inwardly. In some aspects, the elongated free end of the mucosa has a length of at least 5 mm, at least 10 mmm, or at least 20 mm.

In some additional aspects, the elongated free end of the mucosa is positioned in the lumen of the second free end with the assistance of an intraluminal guide member. In some instances, attaching includes approximating the first free end and the second free end using a clamping device. In some instances, attaching is provided by a plurality of staples delivered from a stapler head of the clamping device. In some instances, attaching is provided by tissue welding from RF electrodes in the clamping device. In still other instances, attaching is provided by a plurality of staples in combination with tissue welding provided by the clamping device.

Optionally, approximating the first free end and the second free end comprises approximating the first free end and the second free end in a flattened position. Additionally or optionally, approximating the first free end and the second free end occurs when the first free end and the second free end are in an open-lumen position. In some instances, the intraluminal guide member is configured with suction ports for engaging the elongated free end of the mucosa.

1 8 FIGS.to Referring to the drawings, and initially to, a method of the invention is illustrated for an end-to-end anastomosis in a patient's colon following a resection procedure.

1 FIG. 2 FIG. 100 102 104 105 106 106 104 104 100 110 110 a b is a schematic view of a portion of the patient's colonand mesenterywith a diseased sectionof the colon having a cancerous growth or tumor. Dashed linesandare shown where the diseased sectioncan be resected.illustrates a subsequent step of the method following resection of the diseased portionof the colonleaving a first, healthy free endA of the colon and a second healthy, free endB of the remaining colon.

3 FIG. 4 FIG. 6 FIG. 4 FIG. 116 120 122 110 124 120 122 125 125 124 120 122 110 125 125 140 142 110 125 124 illustrates a subsequent optional step of the method wherein one or more incisionsare made around the muscularisand serosaof the first free endA to assist in dissecting the outer layers(i.e., muscularisand serosa) away from the mucosa. Various tools can be used to grasp the mucosaand to grasp the outer layersto thereafter evert the outer layers.then shows the muscularisand serosaof the first free endA of the colon everted over the non-everted mucosa. The mucosathen has an elongated mucosal free endthat can be used to overlap the interface() between the attached colon segments as will be described below.also shows the second free endB of the colon in an everted configuration without the mucosabeing dissected away from the outer layers.

5 FIG. 144 144 145 146 146 148 148 110 110 150 152 110 152 110 150 140 a b a b b a next illustrates a subsequent step of the method wherein first and second clamping headsA,B of a staplerare inserted into opposing spaces,underlying the everted portions and creases,of the free endsA andB. At the same time, a guide deviceis shown after being introduced through the lumenof the second free endA the lumenof the first free endB. Such a guide deviceis introduced from the exterior of the patient into the patient's colon. The anastomosis is configured obviously so that the mucosal free endextends downstream in the patient's colon.

6 FIG. 5 FIG. 110 110 100 140 110 152 110 144 155 144 155 110 110 b is a sectional view of the first and second free endsA,B of the colonas shown in, wherein the mucosal free endof the first free endA is disposed in the lumenof the second free endB. In this this variation, it can be seen that the first clamping headA carries staplesthat can be actuated by a typical mechanism as is known in the art, and the second clamping headB comprises an anvil for deflecting and bending the staplesto connect the free endsA,B as is known in the art.

7 FIG. 7 FIG. 144 144 110 110 100 140 125 152 110 b shows a subsequent step wherein the first and second clamping headsA,B have been moved toward one another to approximate or clamp together the first and second free endsA,B of the colon. In, it can be seen that the elongated free endof the mucosaextends distally into the lumenof the second free endB.

8 FIG. 8 FIG. 8 FIG. 110 110 100 144 144 140 152 110 142 110 110 142 158 140 220 142 b then illustrates the connection of the first and second free endsA,B of the colonfollowing stapling.also shows the removal of the clamping headsA,B to complete the end-to-end anastomosis procedure. As can be seen in, the mucosal free endextends distally into the lumenof the second free endB and overlaps the interfaceof the free endsA,B and assists in preventing any leakage from the intestine through the stapled interface. It is believed that the overlapping portionof the mucosal free endwill attach and resurface that section of the connected lumen within a matter of days. The length of the dissected mucosal free endpreferably extends at least 5 mm, or at least 10 mm, or at least 20 mm over and past the interfacebetween the attached colon segments.

9 FIG. 6 8 FIGS.- 9 FIG. 6 8 FIGS.- 9 FIG. 6 8 FIGS.- 110 110 100 170 170 172 110 110 100 175 176 180 182 185 175 152 110 110 110 170 170 b shows another variation of an end-to-end anastomosis method and a stapling device similar to the method of. In, the first and second free endsA,B of the colonare clamped together and connected with stapler headsA andB that carry two rows of staples. In this variation, the first and second free endsA,B of the colonare not everted over any substantial length compared to. The intraluminal guidehas an aspiration channel, therein communicating with a negative pressure source. Suction portsin the guide allow for the free endof the mucosa to be suctioned into engagement with the guideand then moved and positioned in the lumenof the second free endB. Thereafter, graspers or other tools can be used to fold outwardly the walls of the first and second free endsA,B for engagement and stapling by the stapler headsA andB. In other aspects, the variation ofis similar to the method of.

10 10 FIGS.A-B 10 FIG.A 10 FIG.A 10 FIG.B 200 210 210 100 200 210 210 200 210 210 220 125 152 210 200 200 220 225 210 210 125 225 220 225 210 210 a show another variation of a method of end-to-end anastomosis that again provided for an elongated dissected mucosal layer that is adapted to overlap the stapled interface. However, in this variation, a conventional type of intraluminal circular stapleris used. In this variation, the first and second free endsA,B of the colonare folded inward, as known in the use of such a circular stapler.shows the free endsA, andB folded inwardly and stapled together after a circular cutter of the staplerhas resected a central portion of the free endsA andB. In, it can be seen that the elongated, dissected free endthe mucosa, has been inverted in the proximal direction into the lumenof the first free endA of the colon before the use of the circular stapler.then shows the withdrawal of the circular staplerand the unfolding de-inverting of the free endof the mucosa in the distal direction to overlap the interfacebetween the connected colon free endsA andB. Thus, this variation also provides for the rapid regrowth of the mucosaover the connection interface, which again can prevent leakage from the intestinal lumen. Again, the length of the dissected mucosa-free endpreferably extends at least 5 mm, or at least 10 mm or at least 20 mm over and past the connection interfacebetween the free endsA andB.

11 FIG. 240 240 100 240 240 250 250 252 252 illustrates another variation of a method of end-to-end anastomosis that again provides the elongated mucosal layer that overlaps an interface between connected colon segmentsA,B of the colon. In this variation, the free ends of the colon segmentsA,B are thermally welded together by means of opposing polarity RF electrodesA andB in the respective clamp membersA andB. The use of RF electrodes and thermal welded connections in intestinal anastomosis is known in the art, for example, as disclosed in U.S. Pat. No. 8,303,610.

It should be appreciated that the inventive aspect of the invention, which comprises providing a dissected mucosal layer positioned to overlap the interface between connected colon segments, includes the use of any connecting or attachment mechanisms, including sutures, staples, thermal welding, magnetic collars or elements, spiked connection collars whether or not bio-erodible, adhesives or any combination thereof. Such connection collars are disclosed in U.S. Pat. Nos. 4,917,090; 5,250,058; 6,524,322, and applications WO2022/171349 and WO2020/225,603.

In addition, the method of everting the colon segments includes the use of everting devices of the types shown in U.S. Patents and applications U.S. Pat. Nos. 6,562,053; 6,575,985; 3,057,355 and U.S. 2005/0043749.

Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.

Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.

All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.